Vadim Klyushnichenko of The Scripps Research Institute works with some 10 CDMOs at any given time. He's developed methodologies for handling due diligence, project and product quality for both drug substance and drug product, and timelines and budgets. But perhaps most instructive is his management — and best practices — for handling all the analytical services his programs require through development and manufacturing at his service providers.
The explosion of gene therapy candidates in clinical development is being led by a diverse set of originators, including many hospital and university labs. While these are great incubators for innovation, the many small labs working in isolation do not have experience in commercializing a medicine for wide and sustained use in patients, and this could slow the acceptance of gene therapies for the people who really need them. Health authorities have recognized the importance of getting gene therapies into standard use and are supporting doing so with accelerated pathways.
Whether improvements in the delivery of training in biopharmaceutical manufacturing are needed is an open question, and the answers are not clear-cut. BioPlan recently conducted independent research to address this question.
Pharma companies ignore the issue of counterfeiting and drug diversion at their own peril. This article discusses noteworthy examples of how drug manufacturers of various sizes are tackling this problem.
This paper includes a discussion on vaccine processes, followed by a case study on the scale-up of upstream and downstream processes for the production of a cell-based live attenuated influenza virus using single-use ReadyToProcess technology.
How starting early, building options into your process, understanding the lead times, and continuing to evaluate your strategy can reduce uncertainty in your plans.
Several characteristics are important to the performance of BPCs, including biological compatibility, physical and mechanical properties, and extractables and leachables (E&L).
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
Collaboration takes many forms; this article will look at how document production, distribution and archiving are affected by the virtual pharma model and in clinical and manufacturing quality settings.
A double-blind, Phase II, placebo-controlled clinical trial to evaluate the safety and efficacy of a novel compound in subjects with mild to moderate Alzheimer’s disease.
For many years it has been almost universally accepted that there are various sources that may impact or cause disease among which biological, social, and environmental differences have all been investigated. Many clinical trials have been conducted to assess the impact of the environment on outcomes e.g., the effect of the environment on the outcome of studies assessing the efficacy of drugs for patients with dry-eye syndrome, the impact of diet on obesity and cardiovascular disease, and the impact of the environment on autoimmune diseases have all been studied, as have many other interactions.
Part two of Marken CEO Wes Wheeler’s ten part blog series about the changing face of Life Science Logistics in today’s fast-paced pharmaceutical industry. By Wes Wheeler, Marken
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By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
Biologics, orphan drugs, and precision medicine are on the rise, and that means some big changes for drug development and manufacturing companies.
Until about 30 years ago, “process R&D” in the pharmaceutical market meant just making a chemical process scalable. Most of the brightest chemists chose to spend their time “discovering” molecules rather than studying how to make them on scale, both efficiently and safely. Adequate attention was not paid to critical aspects of scale-up like safety, waste management, or energy efficiency. The pharmaceutical industry even justified their methods by hypothesizing that the benefit of the end product (life-saving medicines) far outweighed the concerns over the amount of waste that was generated. As a result, the pharmaceutical industry became one of the worst-performing sectors in terms of waste produced per unit of product made. Over the years, the pharma industry has recognized the need to change and develop more efficient processes. Thus a new field of chemistry called process research was born.
To meet therapy production demands, the industry needs to have the right capacity, in the right locations. Increasingly, single-use technologies are being seen as flexible and cost-effective solutions.